On June 13, 2022 Mnemo Therapeutics, a biotechnology company developing transformational immunotherapies, reported the kick-off of their participation in the prestigious Hospital-University Research in Health (RHU) program (Press release, Mnemo Therapeutics, JUN 13, 2022, View Source [SID1234615911]). Designed by France’s National Research Agency, the RHU funding supports cutting-edge research and cross-institutional collaborations, bringing together academia, businesses, and hospitals to push the boundaries of what is possible in healthcare.

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In December of 2021, 17 proposals were selected for the RHU funding. Among them, receiving close to 10 million euros, is the EpCART project. Under the leadership of Sebastian Amigorena, Ph.D., one of Mnemo’s scientific co-founders and head of the Immune Responses and Cancer Team at Institut Curie, the EpCART project aims to clinically validate a novel approach to CAR-T immunotherapy.

"We are honored to be named a laureate for this prestigious initiative and work alongside our long-standing partners at Institut Curie, as well as the MEARY Cell and Gene Therapy Center at Saint-Louis Hospital, AP-HP," said Mnemo CEO, Robert LaCaze.

The EpCART project focuses on epigenetic reprogramming of CAR-T cells. Through the inactivation of SUV39H1, a key enzyme in the differentiation pathway of T cells, the memory phenotype of these cells can be greatly increased. This works to achieve long-lasting tumor control, addressing patient relapse.

"Current immuno-oncology therapies often suffer from immune-cell memory loss, causing therapies to become less active and persistent in their ability to attack cancer cells over time," said Dr. Amigorena. "The EpCART project mines insights into the memory of the immune system to overcome this challenge and produce a new class of CAR-T therapies with enhanced memory and persistence. We believe this will drive more durable responses for cancer patients."

Over the next five years, the EpCART project will seek to clinically validate this technology as an autologous therapy. Mnemo will work in collaboration with the other EpCART partners to conduct a Phase I-II clinical trial, investigating the activity of these innovative CAR-T therapies in a cohort of 35 patients with difficult-to-treat solid tumors.

The EpCART project will accelerate research on Mnemo’s EnfiniT Discovery Engine, an integrated drug discovery tool combining key technologies to create lasting immune memory, identify novel cancer-specific targets, and more.

"Today is an exciting step in our journey to develop transformational immunotherapies with the aim of improving the body’s ability to detect, fight, and overcome cancer," said Mnemo Co-Founder and Chief Operating Officer, Alain Maiore. "We are truly honored to collaborate with such esteemed partners and look forward to the fruits of this initiative."

On June 13, 2022 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for unmet needs in cancer, reported the initiation of patient dosing in TWT-203, its Phase 1b/2 study to evaluate CFI-402257, an oral, best-in-class inhibitor of Threonine Tyrosine Kinase (TTK, also known as MPS1) in patients with advanced solid tumors and ER+/Her2- breast cancer (Press release, Treadwell Therapeutics, JUN 13, 2022, View Source [SID1234615933]). Dosing of the first patient in the trial commenced June 8th at START Mountain Region in Salt Lake City, Utah.

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"Inhibition of TTK, a key mitotic checkpoint, with CFI-402257 represents a novel treatment approach for ER+/Her2-breast cancer, particularly in the context of CDK4/6 inhibitor failure" said Principal Investigator, Dr. Justin A. Call, MD, Director of Clinical Research at START Mountain Region in Salt Lake City, Utah.

"We are excited about the initiation of TWT-203 with our potent and selective TTK inhibitor," said Dr. Michael Tusche, Treadwell co-CEO. "Previous clinical studies have demonstrated that CFI-402257 has a tolerable safety profile and confirmed responses in ER+/Her2- breast cancer after progression on CDK4/6 inhibitors. We look forward to the continued development of this molecule in breast cancer."

The Phase 1b/2 clinical trial of CFI-402257 is an open-label, multi-center, dose optimization study designed to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CFI-402257 as a single agent in advanced solid tumors or in combination with fulvestrant in ER+/Her2- Breast Cancer patients after disease progression on prior CDK4/6 inhibitor and endocrine therapy. The trial will enroll approximately 40 patients at up to 10 sites in the United States. It will include a dose confirming portion in advanced solid tumors and expansions at the Recommended Phase 2 dose as a monotherapy in solid tumors and in combination with fulvestrant in breast cancer patients.

On June 13, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that its prostate cancer imaging agent, Illuccix (kit for preparation of gallium Ga 68 gozetotide), is now available at selected pharmacies in the Jubilant Radiopharma network (Press release, Telix Pharmaceuticals, JUN 13, 2022, View Source [SID1234615949]). Illuccix is now available to order from 139 pharmacy sites across the United States, ensuring scheduling flexibility and patient access to advanced prostate cancer imaging.

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The expansion of the distribution network facilitates broader patient access to Illuccix across the country, expanding availability into new regional markets that to date have had limited access to PSMA PET imaging.

Dr. Christian Behrenbruch, Telix Group CEO and Managing Director said, "A key feature of Illuccix is its flexibility and availability for physicians and patients alike. Our goal is to ensure broad access to PSMA PET imaging from the largest metropolitan cities to regional areas and the expansion of the distribution network to include Jubilant Radiopharma puts an Illuccix scan within reach of even more patients in need."

"We are pleased to be able to expand our range and service to include Illuccix, and offer our customers the added convenience of PSMA PET imaging with Illuccix," says Renato Leite, President, Jubilant Radiopharmacies Division.

On June 13, 2022 Chiome Bioscience Inc. reported that new contract with additional institutes had been finalized and the first patient has been dosed CBA-1205, the first-in-class antibody, in the second part (expansion part) of Phase I study(Press release, Chiome Bioscience, JUN 13, 2022, View Source jp/xcontents/45830/87891347/f845/469b/96ae/2719ff6df264/20220613150323815s.pdf [SID1234625710]).

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In the first part of Phase I study, CBA-1205 exhibited good safety and tolerability. In the second part, two doses will be given to the patients with hepatocellular carcinoma to evaluate safety and to determine the optimum dose for further development. Also, the exploratory efficacy and pharmacokinetics will be investigated.

The study will be conducted at National Cancer Center Hospital, National Cancer Center Hospital East. Additional institutes will be at Kanagawa Cancer Center and Niigata University Medical and Dental Hospital.

We hope that CBA-1205 exhibits good safety and efficacy profile in the second part that is key for early licensing deal. We will announce the progress in a timely manner.

There is no impact on the financial performance in the fiscal period ending December 31, 2022.

＜About CBA-1205＞

CBA-1205 is a humanized IgG1 afucosylated monoclonal antibody targeting cell surface antigen "DLK-1 (Delta-like 1 homolog)" which expresses on hapatocellular carcinoma and other solid cancers. CBA-1205 exhibits potent and specific anti-tumor activity in various DLK1 expressing cancer models by increasing ADCC (antibody-dependent cellular cytotoxicity). DLK-1 is known to control the proliferation and differentiation of stem cells, progenitor cells,
and other immature cells. CBA-1205 is expected to offer a new therapeutic option for the treatment of DLK-1 expressing cancer such as hepatocellular carcinoma. The present phase I clinical study is the first trial all over the world and CBA-1205 exhibited safety and tolerability.

On June 13, 2022 NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported the appointment of Stephan Kutzer, Ph.D. as Interim Chief Executive Officer of Scorpion Biological Services (Press release, NightHawk Biosciences, JUN 13, 2022, View Source [SID1234615934]). Dr. Kutzer currently serves on Scorpion’s advisory board.

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Dr. Kutzer brings more than 25 years of experience in the pharmaceutical and biotech industries, building and managing successful contract development and manufacturing organizations. He previously served as President and Chief Executive Officer of Alcami Corporation, a leading provider of development, analytical testing and manufacturing services to the pharmaceutical and biotech industries. Prior to this, he served as President, Divisional CEO and Chief Operating Officer of the Pharma Biotech & Customer Manufacturing division of Lonza Group AG, a multinational manufacturing company for the pharmaceutical and biotechnology sectors, where he had full oversight of the division, which generated over $1.6 billion in annual sales. He also served as a member of the Executive Management Board of Lonza Group AG; President of Lonza Biologics Inc; Chairman of the Board of Directors of Lonza Singapore Inc; Chairman of the Board of Directors of Teva-Lonza TL Biopharmaceuticals AG; Chairman of the Board of Directors of Lonza Biologics plc.; and President and Chairman of Lonza Inc. Dr. Kutzer previously served as an Executive Director on the board of directors for the Drug, Chemical & Associated Technologies Association (DCAT). Dr. Kutzer earned a master’s degree in Chemical and Process Engineering and a Ph.D. in Engineering Sciences from the Technical University of Munich, Germany.

Jeff Wolf, CEO of NightHawk and Chairman of Scorpion, commented, "Given the dynamic evolution of Scorpion and rapid progress with construction of our San Antonio and Manhattan, Kansas biomanufacturing facilities, we are delighted to welcome Stephan on board. Throughout his more than 25 years in the biomanufacturing space, Stephan has built and managed several successful contract development and global manufacturing organizations. We tapped Stephan from Scorpion’s advisory board to lead Scorpion through its next phase of growth, and we believe his proven track record will be invaluable to our future success."

Commenting on his appointment, Dr. Kutzer stated, "This is an exciting time at Scorpion as we seek to build a robust and fully integrated CDMO. I am honored to have this opportunity and look forward to supporting Scorpion through this next phase of growth."